Ab­b­Vie preps an FDA pitch of promis­ing PhI­II da­ta for block­buster hope­ful elagolix

Hugh Tay­lor

Ab­b­Vie is rolling out the Phase III da­ta it will de­liv­er to the FDA lat­er this year in search of a block­buster ap­proval for elagolix, a top late-stage prospect in their pipeline aimed at crip­pling bouts of en­dometrio­sis. And the in­ves­ti­ga­tors in the study have put some sol­id da­ta on dis­play at the 13th World Con­gress on En­dometrio­sis in Van­cou­ver this af­ter­noon.

In an ab­stract shared with End­points News ear­li­er in the week, Ab­b­Vie re­port­ed that the drug — an oral go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor an­tag­o­nist — demon­strat­ed some clear, dose-de­pen­dent re­spons­es that eas­i­ly out­paced the place­bo arms in two Phase III tri­als, each with more than 800 women en­rolled in them. Both stud­ies tracked clin­i­cal re­spons­es for dys­men­or­rhea — acute and po­ten­tial­ly dis­abling men­stru­al pain — as well as non­men­stru­al pelvic pain.

Ab­b­Vie got this drug in a $575 mil­lion deal it struck in 2010 with Neu­ro­crine $NBIX, which stands to earn a roy­al­ty pay­out on an ap­proval. Just weeks ago Neu­ro­crine won an ap­proval for In­grez­za (val­be­nazine) for tar­dive dysk­i­ne­sia.

In the first elagolix study the low- and high-dose arms reg­is­tered a clin­i­cal re­sponse of 46.4% and 75.8% com­pared to 19.6% of the place­bo arm for dys­men­or­rhea af­ter three months. The sec­ond study de­liv­ered re­mark­ably sim­i­lar re­sults: 43.4% and 72.4% for the low and high dos­es com­pared to 22.7% for the place­bo arm.

The co-pri­ma­ry end­point of non­men­stru­al pelvic pain al­so pro­duced a sta­tis­ti­cal­ly sig­nif­i­cant re­sponse, though the place­bo re­sponse was marked­ly high­er: 50.4% and 54.5% for the two dos­es in one tri­al; 49.8% and 57.8% for the sec­ond tri­al. The place­bo pa­tients ex­pe­ri­enced a 36.5% re­sponse.

“That’s ex­act­ly what I would have ex­pect­ed,” lead in­ves­ti­ga­tor Hugh Tay­lor tells me. With reg­u­lar men­stru­al pain women are more like­ly to bet­ter gauge the drug’s im­pact, while non­men­tru­al pelvic pain can be more vari­able and there­fore more like­ly to leave it­self open to the kind of place­bo re­sponse that many pain drug stud­ies are sus­cep­ti­ble to.

Tay­lor says he rou­tine­ly treats this ail­ment in his prac­tice and ex­pects that an ap­proval will ush­er in a new stan­dard for treat­ing en­dometrio­sis.

“It’s not well rec­og­nized,” he says, “usu­al treat­ed (ini­tial­ly) with oral con­tra­cep­tives, which of­ten don’t work or on­ly par­tial­ly, with side ef­fects…. Hav­ing new op­tions will bring an uptick in recog­ni­tion.” And with added recog­ni­tion, he adds, you can ex­pect to find more docs us­ing elagolix.

Right now the gen­er­al con­sen­sus in the med­ical com­mu­ni­ty is that about 5% to 10% of women in their re­pro­duc­tive years suf­fer from dis­abling bouts of this ail­ment.

An­oth­er late-stage pro­gram for elagolix has been un­der­way for uter­ine fi­broids, which an­a­lysts be­lieve will like­ly be an­nounced in Q3. The cur­rent study for en­dometrio­sis is be­ing pub­lished in the New Eng­land Jour­nal of Med­i­cine.

Ab­b­Vie has been mov­ing sys­tem­at­i­cal­ly to­ward fil­ing the drugs, de­clar­ing its sec­ond Phase III suc­cess for this drug more than a year ago. A spokesper­son for the com­pa­ny says the fil­ing will come lat­er this year. And some an­a­lysts fol­low­ing the com­pa­ny have tapped it as a drug like­ly to earn more than a bil­lion dol­lars a year, mark­ing it as a sig­nif­i­cant part of Ab­b­Vie’s mul­ti-bil­lion dol­lar ef­fort to pre­pare for a day when Hu­mi­ra will no longer be able to de­liv­er the bulk of its rev­enue.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.